BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2080713 · Received May 6, 2011

    Report

    Report Number
    2649622-2011-07452
    Event Type
    Death
    Date Received
    May 6, 2011
    Date of Event
    February 3, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS REVEALED NORMAL BATTERY DEPLETION. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, NOT ANALYZED DUE TO THE INVOLVEMENT IN A LEGAL CASE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, PRIMARY ANALYSIS REVEALED NO ANOMALIES FOUND. ADDITIONALLY NOTED WAS OUTER INSULATION WAS MELTED, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND PRIMARY ANALYSIS RESULTS REVEALED NO ANOMALIES FOUND. ADDITIONALLY NOTED WAS AN OUTER INSULATION BREACH, OUTER INSULATION COSMETIC DEPRESSION, AND APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    AN ATTORNEY ALLEGES THAT THE "PATIENT SUFFERED REPEATED SHOCKS AND FRACTURES, AFTER THE ENHANCED MONITORING SYSTEM WAS IN PLACE, AND THE MONITORING FAILED." THE PATIENT EXPIRED ON 03 FEB 2008. A NOTE FROM THE PATIENTS PHYSICIAN STATES THAT THE PATIENT HAD "DIED FROM INTERNAL BLEEDING AND HIS DEATH WAS NOT LIKELY RELATED TO HIS HEART CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death| H| L| R